Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients

• ClinicalTrials.gov Identifier: NCT02427399
• Recruitment Status: Completed
• First Posted: April 28, 2015
• Results First Posted: June 22, 2017
• Last Update Posted: June 22, 2017
• Sponsor: Fenway Community Health
• Information provided by (Responsible Party): Jenny Potter, Fenway Community Health

Study Description

Brief Summary:

The purpose of this project is to determine whether outreach to HIV-negative patients who are overdue for a Pap smear at a New England urban community health center can increase cervical cancer screening rates. It additionally seeks to determine which form of outreach - via letter, email, phone, or a mixture of those modalities- is most effective among these patients.

Condition or disease	Intervention/treatment	Phase
Uterine Cervical Neoplasms	Other: Letter and informational sheet; Other: Email; Other: Phone; Other: Multimodal	Not Applicable

Detailed Description:

To the investigators' knowledge, this study will be the first to assess the efficacy of email in cervical cancer screening outreach in a randomized controlled trial. It will also be one of the few randomized controlled trials to directly compare different outreach media directly, as opposed to different variations within a single medium (e.g. two different types of letters). Lastly, given the unique patient demographic makeup at Fenway, including a significant number of lesbian, bisexual and transgender patients, secondary subanalyses have the potential to significantly add to the investigators' knowledge of what media work best in conducting cervical cancer screening outreach with sexual and gender minorities, who are disproportionately underscreened compared to heterosexual cis-gendered women.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1100 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients at an Urban Community Health Center
• Study Start Date: January 2013
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: January 2017

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Usual care / opportunistic screening; This group will not be contacted by the study team in any way and will receive the general standard of care at Fenway. Patient charts are reviewed by the provider and medical team shortly before a scheduled visit to determine if the patient is due for a Pap, and if so, the patient is offered a Pap during the visit or the chance to schedule one for another date. Any proactive outreach occurs infrequently and at an ad-hoc basis, but should any proactive outreach occur, the study team will not interfere.
Experimental: Letter and informational sheet; The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests. If the patient does not contact Fenway within 1 month to schedule an appointment, an additional letter will be sent at 1 month, and similarly again at 2 months. These letters will be the same, except that letters two and three will mention that previous attempts have been made at contact. Based on best practices in the literature, the letters will be signed by the patient's primary care provider.	Other: Letter and informational sheet; The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests.
Experimental: Email; The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders. The email will be sent from the provider's email account. The email will have an informational sheet attached or included in the body of the email. The emails will be sent through MyFenway, the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant patient contact system at Fenway.	Other: Email; The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders.
Experimental: Phone; The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. As per HIPAA regulations, if the patient does not answer, a voicemail will be left saying that a Fenway representative has called and request that the patient calls back, but a reason will not be given. Some, but not all of the information contained in the info sheet will be provided during the call (see phone script). The script used is consistent with the scripts used currently for patient outreach. A voicemail will still count as one outreach attempt out of three. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.	Other: Phone; The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.
Experimental: Multimodal; The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called. If a patient randomly selected for this group does not have an email listed, she will receive one letter and two phone calls.	Other: Multimodal; The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called.

Outcome Measures

Primary Outcome Measures :

1. Proportion of Patients Who Receive a Pap Test at End of Follow up [ Time Frame: 18 months ]
   The outcome will be ascertained for each patient through chart review. The effectiveness of each intervention will be assessed through a comparison of screening rates between each of the four intervention arms (letter, email, phone, letter/email/phone) and the control arm (usual care/opportunistic screening).

Secondary Outcome Measures :

1. Proportion Receiving Pap Test at 6 Months [ Time Frame: 6 months ]
   The outcome will be ascertained for each patient through chart review. The effectiveness of each intervention will be assessed through a comparison of screening rates between each of the four intervention arms (letter, email, phone, letter/email/phone) and the control arm (usual care/opportunistic screening).
2. Proportion Receiving Pap Test at 12 Months [ Time Frame: 12 months ]
   The outcome will be ascertained for each patient through chart review. The effectiveness of each intervention will be assessed through a comparison of screening rates between each of the four intervention arms (letter, email, phone, letter/email/phone) and the control arm (usual care/opportunistic screening).

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 64 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Female or female-to-male transgender patients with a cervix
• HIV-negative
• Medical appointment at Fenway Community Health during calendar year 2012 who have not had a Pap smear in the past 3 years (since January 2010)

Exclusion Criteria:

• HIV-positive (due to different Pap testing guidelines)
• Male-to-female transgender patients
• Patients with a history of a hysterectomy, unless specified as partial or supracervical
• Patients aged 30-64 who had a negative Pap test in the past 5 years with simultaneous negative Human papillomavirus infection (HPV) co-testing

Contacts and Locations

Sponsors and Collaborators

Fenway Community Health

Investigators

• Principal Investigator: Jennifer Potter, MD; Fenway Community Health

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Peitzmeier SM, Khullar K, Potter J. Effectiveness of four outreach modalities to patients overdue for cervical cancer screening in the primary care setting: a randomized trial. Cancer Causes Control. 2016 Sep;27(9):1081-91. doi: 10.1007/s10552-016-0786-6. Epub 2016 Jul 22.

• Responsible Party: Jenny Potter, Principal Investigator, Fenway Community Health
• ClinicalTrials.gov Identifier: NCT02427399
• Other Study ID Numbers: Cervical Cancer Screening
• First Posted: April 28, 2015
• Results First Posted: June 22, 2017
• Last Update Posted: June 22, 2017
• Last Verified: June 2017

Additional relevant MeSH terms:

Uterine Cervical Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases